FDA 510(k)

MedicVOD System

K-Number: K151737 · 2016-02-25

Decision Date2016-02-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MedicVOD System is the device name listed in this FDA 510(k) record. The listed applicant is Orpheus Medical , Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K151737. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedicVOD System?

MedicVOD System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Orpheus Medical , Ltd.. The 510(k) number is K151737.

When did MedicVOD System receive FDA 510(k) clearance?

MedicVOD System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K151737.

Who is the listed applicant for MedicVOD System?

The FDA 510(k) record lists Orpheus Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedicVOD System?

The FDA product code for MedicVOD System is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.